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FDA 510(k)

StealthStation S8 System Platforms and StealthStation Cranial Software

K-Number: K162309 · 2017-03-31

ApplicantMedtronic Navigation, Inc.
Decision Date2017-03-31
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation S8 System Platforms and StealthStation Cranial Software is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2017-03-31 under approval number K162309. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthStation S8 System Platforms and StealthStation Cranial Software?

StealthStation S8 System Platforms and StealthStation Cranial Software is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K162309.

When was StealthStation S8 System Platforms and StealthStation Cranial Software approved by the FDA?

StealthStation S8 System Platforms and StealthStation Cranial Software received FDA 510(k) clearance on 2017-03-31, under approval number K162309.

What company makes StealthStation S8 System Platforms and StealthStation Cranial Software?

StealthStation S8 System Platforms and StealthStation Cranial Software is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation S8 System Platforms and StealthStation Cranial Software?

The FDA product code for StealthStation S8 System Platforms and StealthStation Cranial Software is HAW.

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Related PubMed Literature

PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022)

Other Devices by Medtronic Navigation, Inc.

K162604Cranial Reducing Tubes K153660StealthStation System with Cranial Software K153555EM ENT Navigated Suctions K153247Fusion Compact Navigation System K170018StealthStationTM S8 ENT Software K162655StealthConnect Remote Viewing, Planning and Collaboration System

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Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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